FDA holds ground against petitions to ban ortho-phthalates in food packaging materials

25 Jul 2023 --- The US Food and Drug Administration (FDA) has denied a petition requesting that it reconsider its decision not to ban the use of eight ortho-phthalates in food contact packaging materials.

The agency also rejected calls for a revocation of five previous sanctions on five other ortho-phthalates, which are said to pose severe threats to human health as they leach into F&B products. The FDA rejected the claims that it is legally required to consider exposure to phthalates from non-dietary sources. 

A central problem in ridding F&B packaging of phthalates is that many plastic types rely on the chemicals as softeners, which are difficult to replace in materials like polyvinyl chloride. 

The citizen petition, launched in May last year, was submitted by the non-profit organization EarthJustice and Canadian American pediatric infectious disease physician and epidemiologist Katherine K. O’Brien, among others. 

“To rationally assess whether a substance is safe for use in food, FDA cannot rely on the erroneous assumption that diet is the only source of exposure where the available evidence demonstrates that people also are exposed from other sources,” reads the petition.  

“Even low dose exposures may have a relevant biologic effect when combined with elevated background levels.” 

Plasticizer pollutants 
In 2021, the FDA was sued by eight environmental and human health organizations, including EarthJustice, for failing to ban phthalate chemicals from F&B packaging, despite years of research proving potential dangers to human and environmental health.

Linked to cardiovascular disease, lowered IQ, hormone disruption and impaired sexual development, researchers connected the chemicals to over 100,000 US deaths annually.

A study published in Environmental Pollution also estimated that the healthcare impact and loss of life associated with cardiovascular disease could cost the US up to US$47 billion each year. 

“FDA is sitting on years of scientific evidence that phthalates used in food packaging and processing materials are dangerous to human health,” said O’Brien. “While FDA idles, babies and children are consuming phthalates in their food that endanger their brain development and long-term health.”

Edited by Louis Gore-Langton